Addition of Acetaminophen in Standard PDA Management

University of Florida

Status and phase: Withdrawn; Phase 2

Conditions: Patent Ductus Arteriosus

Treatments: Drug: Intravenous Ibuprofen; Drug: Intravenous Ibuprofen + Oral Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT04026464

IRB201901829 -A

Details and patient eligibility

About

Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.

Sex: All

Ages: 23 to 28 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight < 1000 grams

• Hemodynamically significant PDA as defined by any of the following:

  1. Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
  2. Hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below the infants' post menstrual age)
  3. Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)

• Echocardiographic criteria:

  1. Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery > 0.5

Exclusion criteria

• No enteral feedings
• PDA-dependent congenital heart disease
• Prior treatment with prophylactic indomethacin
• Prior PDA treatment with any medications
• Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation
• Abnormal liver enzymes (ALT > 60 IU/L and AST > 60 IU/L)
• Platelets count < 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding
• Major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect
• Prior enrollment to other interventional clinical study where PDA is an outcome variable

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Ibuprofen+Acetaminophen Group

Active Comparator group

Description:

Infants with PDA randomized to the combined treatment group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) and oral acetaminophen (15 mg/kg oral acetaminophen \[160 mg/5ml concentration\] every 6 hours for a total of 12 doses).

Treatment:

Drug: Intravenous Ibuprofen + Oral Acetaminophen

Ibuprofen Group

Placebo Comparator group

Description:

Infants with PDA randomized to the control mono therapy group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) alone.

Treatment:

Drug: Intravenous Ibuprofen